The regulation outlined in Title 21, Part 211, Subpart C of the Code of Federal Regulations focuses on the design and construction features of buildings and facilities used in the manufacturing, processing, packing, and holding of drug products. This regulation, administered by the Food and Drug Administration (FDA), falls under the broader framework of Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals. By establishing guidelines for suitable building design, adequate space, and defined operational areas, the regulation aims to facilitate proper operations, prevent contamination, and ensure the safety and quality of pharmaceutical products.
Suitable Size, Construction, and Location
The first requirement set forth by the regulation emphasizes that any building or buildings utilized in the drug product manufacturing process should be of suitable size, construction, and location. This criterion serves several important purposes, including facilitating cleaning, maintenance, and proper operations. By ensuring adequate space, manufacturers can effectively organize equipment and materials, thereby minimizing the risk of mix-ups between different components, drug product containers, closures, labeling, in-process materials, or final drug products.
Preventing Contamination and Mix-ups
Contamination and mix-ups present significant risks to the quality and safety of pharmaceutical products. To address this concern, the regulation mandates that the flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings must be carefully designed to prevent contamination. This requirement necessitates the implementation of appropriate control systems and defined areas to ensure the separation and organization of materials throughout the manufacturing process.
Specifically Defined Operational Areas
The regulation stipulates that operations must be performed within specifically defined areas of adequate size. These designated areas, or control systems, play a crucial role in preventing contamination and mix-ups during various procedures involved in pharmaceutical manufacturing. The following procedures require separate areas or control systems to ensure product integrity:
Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling before quality control testing or examination.
Holding rejected components, drug product containers, closures, and labeling prior to disposition.
Storage of released components, drug product containers, closures, and labeling.
Storage of in-process materials.
Manufacturing and processing operations.
Packaging and labeling operations.
Quarantine storage before the release of drug products.
Storage of drug products after release.
Control and laboratory operations.
Aseptic processing, which includes specific requirements for maintaining cleanliness and sterility, such as smooth, cleanable surfaces, temperature and humidity controls, filtered air supply, environmental monitoring, and equipment maintenance.
Separate Facilities for Penicillin Production
To further ensure safety, facilities involved in the manufacture, processing, and packing of penicillin must be physically separated from those used for other drug products intended for human use. This requirement reflects the unique risks associated with penicillin production and underscores the need to prevent cross-contamination and mitigate potential allergic reactions in sensitive individuals.
The regulations outlined in Title 21, Part 211, Subpart C of the Code of Federal Regulations establish critical guidelines for the design and construction features of buildings and facilities used in the pharmaceutical industry. By adhering to these regulations, pharmaceutical manufacturers can ensure suitable building design, adequate space for proper operations, and the prevention of contamination and mix-ups. Such measures ultimately contribute to the production of safe, high-quality finished pharmaceutical products, thereby safeguarding public health and maintaining consumer confidence in the pharmaceutical industry.